meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
1995-06-28

Clearances · page 120 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K952317 Kaplan-Simpson InfusaSleeve II Catheter Localmed, Inc. QEY Class II 1995-06-28
K945626 QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH Quinton, Inc. DPS Class II 1995-06-28
K946306 SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM Siemens Medical Solutions USA, Inc. DSI Class II 1995-06-27
K943390 FLEXFINDER GUIDEWIRE Flexmedics DQX Class II 1995-06-27
K945198 DIDECO PEDIATRIC ARTERIAL FILTERS Sorin Biomedical, Inc. DTM Class II 1995-06-27
K951313 MEDAMICUS PERCUTANEOUS INTRODUCER Medamicus, Inc. DYB Class II 1995-06-27
K941898 MEMORYTRACE ATM MODEL 4222 Hi-Tronics Designs, Inc. DXH Class II 1995-06-26
K945111 DYNAPULSE 5000A (DP5000A) Pulse Metric, Inc. DXN Class II 1995-06-23
K951508 STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM Boston Scientific Corp DTK Class II 1995-06-22
K951248 BRAUN PTA BALLOON CATHETER B.Braun Medical, Inc. LIT Class II 1995-06-22
K951720 SCIMED EXPO ANGIOGRAPHIC CATHETER Scimed Life Systems, Inc. DQO Class II 1995-06-22
K951307 BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES Baxter Healthcare Corp DQX Class II 1995-06-22
K950216 SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-06-22
K944567 COWBOY X Kinetic Concepts, Inc. JOW Class II 1995-06-21
K952064 FOCUS BALLOON DILATATION CATHETER Cardiovascular Dynamics, Inc. LIT Class II 1995-06-21
K941473 MAXIMA PLUS HOLLOW FIBER OXYGENATOR Medtronic Vascular DTZ Class II 1995-06-21
K942391 BRAUN MANIFOLD B.Braun Medical, Inc. DTL Class II 1995-06-21
K945666 EVOLUTION(TM) MICROCATHETER Boston Scientific Corp KRA Class II 1995-06-21
K946352 LEMAITRE VALVULOTOME II Vascutech, Inc. MGZ Class II 1995-06-21
K945836 1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES Conmed Andover Medical, Inc. DRX Class II 1995-06-20
K951368 CARBOMEDICS EXENDED MITRAL ROTATOR Carbomedics, Inc. MOP Class I 1995-06-20
K944860 SCHOLAR PATIENT MONITOR Criticare Systems, Inc. MHX Class II 1995-06-20
K943709 DINAMAP PLUS VITAL SIGNS MONOITOR Critikon Company, LLC DPS Class II 1995-06-16
K951509 PULSE*SPRAY INFUSION SYSTEM Angiodynamics, Div. E-Z-Em, Inc. QEY Class II 1995-06-16
K934086 MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE Medrad, Inc. DXT Class II 1995-06-15
K912035 STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY Boston Scientific Corp DTK Class II 1995-06-15
K951602 PULSE*SPRAY INFUSION SYSTEM Angiodynamics, Div. E-Z-Em, Inc. KRA Class II 1995-06-14
K951088 QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS Quest Medical, Inc. DWF Class II 1995-06-14
K942927 0.035 IN. WISE WIRE Boston Scientific Corp DQO Class II 1995-06-13
K951109 C-THRU CORONARY GUIDE WIRE Schneider (Europe) GmbH DQX Class II 1995-06-08
K943862 SONICAID MODEL MR-63 AMBULATORY ECG RECORDER Oxford Instruments Medical Systems DSH Class II 1995-06-07
K943948 PROTECTIVE SHORTS Y. Daneshvar, M.D. DXC Class II 1995-06-05
K945379 PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING Boston Scientific Corp DQX Class II 1995-06-05
K934913 HEARTRAC ECG MONITORING SYSTEM Cardiac Telecom Corp. QYW Class II 1995-06-05
K952085 DPD DEFIBRILLATOR Medical Research Laboratories, Inc. LDD Class II 1995-06-05
K943358 NAVIGUIDE HYDROPHILIC GUIDE WIRE Meadox Medicals, Div. Boston Scientific Corp. DQX Class II 1995-06-02
K944495 MODEL 3200 VASCULAR MINI-LAB Parks Medical Electronics, Inc. MHX Class II 1995-06-02
K945909 NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER Navarre Biomedical , Ltd. KRA Class II 1995-06-02
K943934 AORTIC ARCH CANNULAS Sorin Group Italia S.R.L. DWF Class II 1995-06-02
K951089 SCIMED GATEWAY PLUS Scimed Life Systems, Inc. DTL Class II 1995-05-31
K932388 HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER Heart Rhythm Technologies, Inc. DRF Class II 1995-05-31
K950855 ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS Adam Spence Corp. DQO Class II 1995-05-30
K950814 QUEST ANTEGRADE CARDIOPLEGIA CANNULA Quest Medical, Inc. DWF Class II 1995-05-25
K950835 SCIMED CHOICE PT PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-05-25
K935877 NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A Nihon Kohden America, Inc. DSI Class II 1995-05-24
K950687 EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) Belmont Instrument Corp. DSP Class II 1995-05-24
K944422 BSM-8800A BEDSIDE MONITOR Nihon Kohden America, Inc. DSI Class II 1995-05-24
K942881 TC 3000 Gaymar Industries, Inc. DWJ Class II 1995-05-23
K950483 HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR Hewlett-Packard Co. DRO Class II 1995-05-22
K945904 SCIMED(R) VENTURE(TM) II INFUSION CATHETER Scimed Peripheral Interventions KRA Class II 1995-05-19
K945065 DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 Sorin Biomedical, Inc. DTN Class II 1995-05-19
K946273 1700 MONITORING ECG ELECTRODE Conmed Andover Medical, Inc. DRX Class II 1995-05-17
K950119 OPTA 5(TM) 5F PTA BALLOON CATHETER Cordis Corp. LIT Class II 1995-05-17
K942058 SPACELABS MEDICAL ECG MODULE (MODEL 90492) Spacelabs Medical, Inc. DSI Class II 1995-05-17
K950536 PICIS CHART+ Picis MHX Class II 1995-05-17
K950486 GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE Graphic Controls Corp. DRX Class II 1995-05-17
K945638 TELPHONIC STETHOSCOPE American Telecare, Inc. DQD Class II 1995-05-17
K950907 PULSE*SPRAY INFUSION SYSTEM Angiodynamics, Div. E-Z-Em, Inc. QEY Class II 1995-05-17
K950487 GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE Graphic Controls Corp. DRX Class II 1995-05-17
K950909 TRANSIT-2 INFUSION CATHETER Cordis Neurovascular, Inc. DQO Class II 1995-05-16
K950751 TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES Medtronic Vascular DXY Class III 1995-05-15
K950586 AVD INTIMAX THROMBECTOMY CATHETER Applied Medical Resources DXE Class II 1995-05-15
K946188 CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER Cardiac Control Systems, Inc. DXY Class III 1995-05-15
K950752 ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS Advanced Cardiovascular Systems, Inc. DQX Class II 1995-05-15
K942347 NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 Nellcor, Inc. DQA Class II 1995-05-12
K944262 ECG MONITOR Fukuda Denshi USA, Inc. DRT Class II 1995-05-12
K922528 CMS SYSTEM Micromedical Industries, Ltd. DQK Class II 1995-05-12
K951347 MARINR SERIES EP DIAGNOSTI CATHETERS Medtronic Cardiorhythm DRF Class II 1995-05-10
K942072 MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND Mabis Healthcare, Inc. DXN Class II 1995-05-10
K942586 CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) Telescan Medical Systems DXH Class II 1995-05-10
K942653 HOLTER SSR DIGICORDER(TM) Del Mar Avionics DSH Class II 1995-05-10
K945384 1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED Siemens Medical Solutions USA, Inc. DSI Class II 1995-05-10
K941215 VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR Sorin Biomedical, Inc. DTN Class II 1995-05-10
K945071 PROPAQ 200 MONITOR Protocol Systems, Inc. DRT Class II 1995-05-10
K952164 EMI MODEL FFF-IA New York Heart Instruments, Inc. DQK Class II 1995-05-10
K951502 CVD BULLET INFUSION CATYHETER Cardiovascular Dynamics, Inc. KRA Class II 1995-05-10
K944395 ELCAT D-PPG, PLETHYSMOGRAPH DEVICE Dermatology Assoc. JOM Class II 1995-05-10
K945230 ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON Arrow Intl., Inc. DSP Class II 1995-05-09
K950492 ATRAUMAX SURGICAL CLAMP Applied Medical Resources DXC Class II 1995-05-08
K951005 KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) Kenex , Ltd. IZQ Class II 1995-05-04
K951503 CVD BULLETT HI-FLO INFUSION CATHETER Cardiovascular Dynamics, Inc. KRA Class II 1995-05-04
K951744 LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS Boston Scientific Corp DRF Class II 1995-05-04
K933417 ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER Echocath, Inc. DRF Class II 1995-05-04
K943124 HEARTRAK Universal Medical, Inc. DXH Class II 1995-05-03
K950210 CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER Cardiac Control Systems, Inc. DXY Class III 1995-05-03
K943123 PACETRAK Universal Medical, Inc. DXH Class II 1995-05-03
K935909 CG-1000 PERSONAL ECG TRANSMITTER Card Guard Scientific Survival , Ltd. DXH Class II 1995-04-28
K950534 SCIMED SCEPTOR PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-04-28
K944267 HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA Cobe Cardiovascular, Inc. DTR Class II 1995-04-28
K950535 SCIMED SCEPTOR EXCHANGE GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1995-04-28
K950352 PRECEDER GUIDEWIRE Boston Scientific Corp DQX Class II 1995-04-28
K944353 SIMON NITINOL FILTER Nitinol Medical Technologies, Inc. DTK Class II 1995-04-28
K944989 NOPROFILE OLBERT CATHETER SYSTEM Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1995-04-26
K945524 CORDIS INTRODUCING CATHETER Cordis Corp. DYB Class II 1995-04-26
K935020 OMNI-TRAC MODIFICATION Invivo Research, Inc. MLD Class II 1995-04-26
K950779 HEART RATE VARIABILITY SOFTWARE OPTION Spacelabs, Inc. DPS Class II 1995-04-25
K941262 MARQUETTE DEFIB ELECTRODE Marquette Electronics, Inc. MKJ Class III 1995-04-20
K933451 OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION Electro-Catheter Corp. DRF Class II 1995-04-19
K930564 HOLTER FOR WINDOWS North East Monitoring, Inc. DQK Class II 1995-04-19
K933450 CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION Electro-Catheter Corp. DRF Class II 1995-04-19

19,212 clearances in the Cardiovascular panel. Data: openFDA.